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Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms (ICD-EGMs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00916435
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University

Tracking Information
First Submitted Date June 8, 2009
First Posted Date June 9, 2009
Last Update Posted Date April 21, 2015
Study Start Date March 2005
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2015)
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP) [ Time Frame: from enrollment up to 72 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00916435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 19, 2015)
  • Composite heart failure outcome (HF hospitalization, HF death, heart transplant) [ Time Frame: from enrollment up to 72 months ]
  • All-cause mortality [ Time Frame: from enrollment up to 72 months ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
Official Title Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
Brief Summary

The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:

  • to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
  • to predict progression of heart failure in patients with ICD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death
Condition
  • Congestive Heart Failure
  • Sudden Cardiac Death
  • Arrhythmia
  • Cardiomyopathies
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2009)
630
Original Actual Enrollment Same as current
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • history of acute MI at least 4 weeks old
  • non-ischemic LV dysfunction for at least 9 months
  • who have an EF < or = to 35%
  • who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
  • undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD

Exclusion Criteria:

  • inability or unwillingness to provide valid informed consent
  • pregnancy
  • any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00916435
Other Study ID Numbers 1K99HL094665-01 (in review)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Larisa Tereshchenko, Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Washington University School of Medicine
Investigators
Principal Investigator: Larisa G Tereshchenko, MD, PhD Johns Hopkins University
Principal Investigator: Ronald D Berger, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2015